Dietary Carbohydrate Type and Cardiovascular Disease (CVD) Risk Indicators
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Purpose
The aim of this study is to determine the effect of habituation to diets with different types of carbohydrate (simple-carb, refined-carb, unrefined-carb) on selected Cardiovascular Disease (CVD) risk indicators.
| Condition | Intervention |
|---|---|
|
Dyslipidemia |
Other: Diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Dietary Carbohydrate Type and CVD Risk Indicators |
- fasting plasma lipid profile [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
- glucose [ Time Frame: 15 week period ] [ Designated as safety issue: No ]
- insulin [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
- adipose tissue inflammatory markers [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
- gut microbiome [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
- High-sensitivity C-reactive protein(hsCRP) [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
- Interleukin 6 (IL-6) [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
- Monocyte Chemoattractant Protein 1 (MCP-1) [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
- Tumor necrosis factor-alpha (TNF-alpha) [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
- Monocyte gene expression [ Time Frame: 15-week period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Unrefined-carbohydrate
unrefined carbohydrate diet
|
Other: Diet
Unrefined-carbohydrate refers to foods made with 100% whole grains (wheat, rice, corn). Refined-carbohydrate refers to foods made with white flour (e.g., bread, pasta) or white rice. Simple-carbohydrate refers to foods made with sucrose (50% glucose/50% fructose) and high-fructose corn syrup.
Other Names:
|
|
Refined-carbohydrate
refined carbohydrate diet
|
Other: Diet
Unrefined-carbohydrate refers to foods made with 100% whole grains (wheat, rice, corn). Refined-carbohydrate refers to foods made with white flour (e.g., bread, pasta) or white rice. Simple-carbohydrate refers to foods made with sucrose (50% glucose/50% fructose) and high-fructose corn syrup.
Other Names:
|
|
Simple-carbohydrate
simple carbohydrate diet
|
Other: Diet
Unrefined-carbohydrate refers to foods made with 100% whole grains (wheat, rice, corn). Refined-carbohydrate refers to foods made with white flour (e.g., bread, pasta) or white rice. Simple-carbohydrate refers to foods made with sucrose (50% glucose/50% fructose) and high-fructose corn syrup.
Other Names:
|
Detailed Description:
The objective of this pilot study is to determine the relative comparability for an isocaloric exchange of (1) refined-carb for simple-carb and (2) refined-carb for unrefined-carb, on established and emerging CVD risk indicators. To achieve this goal, subjects with moderate dyslipidemia (LDL cholesterol > 100mg/dL) will consume diets enriched in 3 types of carbohydrate (simple-carb, refined-carb and unrefined-carb) according to a randomized, cross-over design.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- LDL cholesterol (>100 mg/dL)
- > 50 years (all females postmenopausal, as defined by complete natural cessation of menses for > 12 months or a bilateral oophorectomy)
- BMI > 25 and < 35 kg/m2
- Normal kidney function as assessed by serum creatinine and blood urea nitrogen
- Normal liver function as assessed by serum glutamic oxaloacetic transaminase and alkaline phosphatase
- Normal thyroid function as assessed by serum thyroid stimulating hormone concentrations
- Normal gastrointestinal function
- Fasting plasma glucose concentrations < 120 mg/dL
- Normotensive with or without medication
- Non-smoker for at least 12 months
- Alcohol intake of less than 7 drinks per week
- Consistent physical activity pattern
Exclusion Criteria:
- < 50 years old
- BMI < 25 and > 35 kg/m2
- LDL cholesterol < 100 mg/dL
- Abnormal fasting plasma glucose levels > 120 mg/dL
Use of medications known to affect lipid metabolism:
- Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- Fibrates (Gemfibrozil [Lopid], Ciprofibrate, Fenofibrate [Tricor], etc)
- Probucol
- Use of anticoagulants (Coumadin, Heparin, Plavix, etc), anabolic steroids, and hydrocortisone.
- Use of hormone therapy medications containing estrogen
- Use of fish oil/omega-3 supplements, and Metamucil (or fiber containing dietary supplements)
- Any Aspirin, non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use or therapies that cannot be discontinued by subject for 72 hours prior to and 72 hours after fat biopsy procedure.
- Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis > 50%, angina and peripheral arterial disease
- Untreated hypertension, defined as systolic blood pressure (SBP) > 140 mm and diastolic blood pressure (DBP) > 90 mm
- Renal or kidney disease, as defined by a history of chronic kidney disease or by glomerular filtration rate of < 60 ml.min/1.73 m2 calculated from screening blood tests
- Liver disease, as defined by a history of chronic hepatitis B or C, cholestatic or cirrhotic liver disease, nonalcoholic fatty liver disease, elevations of serum glutamic pyruvic transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) greater than 1.5 times the upper limit of normal at screening, bilirubin greater than 2 mg/dL (in the absence of benign causes of elevated bilirubin such as Gilbert's syndrome) at screening, or albumin below the lower limit of normal
- Hypothyroidism or hyperthyroidism, defined as screening thyroid stimulating hormone (TSH) outside of normal ranges (< 0.4 or > 4.5), unless controlled with medication for at least 6 months
- Type I and II diabetes
- Gastrointestinal disease
- Lidocaine Allergy
- Smoking within the past 12 months.
- Alcohol intake > 7 drinks per week or unwillingness to not consume alcohol while participating in the study
- Unwillingness to maintain body weight during participation in the study
- Unwillingness to adhere to diet and study protocol
- Weight gain or loss of more than 15 lb within 6 months prior to enrollment
- Non-English speaking subjects
Contacts and Locations| Contact: Alice H. Lichtenstein, D.Sc. | (617) 556-3127 | alice.lichtenstein@tufts.edu |
| Contact: Nirupa R. Matthan, Ph.D. | (617) 556-3114 | nirupa.matthan@tufts.edu |
| United States, Massachusetts | |
| Jean Mayer Human Nutrition Research Center on Aging | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Volunteer Services 800-738-7555 volunteers-hrnc@tufts.edu | |
| Principal Investigator: Alice H. Lichtenstein, D. Sc. | |
| Sub-Investigator: Stefania Lamon-Flava, M.D., Ph.D. | |
| Sub-Investigator: Nirupa Matthan, Ph.D. | |
| Principal Investigator: | Alice H. Lichtenstein, D.Sc. | Tufts University |
More Information
No publications provided
| Responsible Party: | Tufts University |
| ClinicalTrials.gov Identifier: | NCT01610661 History of Changes |
| Other Study ID Numbers: | 2735 |
| Study First Received: | November 7, 2011 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Tufts University:
|
carbohydrate inflammation glucose homeostasis gene expression |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013